Influence of the Nebulizer on the Clinical Efficacy of Hypertonic Saline 3% in Children Aged Less Than 18 Months and Hospitalized With Acute Viral Bronchiolitis

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Acute Viral Bronchiolitis

Treatments: Device: nebulisations

Study type: Interventional

Funder types: Other

Identifiers

NCT01295398

2010-A01237-32

2010-24 (Other Identifier)

Details and patient eligibility

About

The aim of the investigators study is to compare in children aged less than 18 months and hospitalized for an acute viral bronchiolitis the efficacy of the HS 3% (Mucoclear®, sterile ampoules of 4 ml) nebulised with a conventional jet-nebulizer (particles diameter of 4-5 µm), or with a jet-nebulizer adapted for infants (particles diameter of 2-2.5 µm), or with a mesh-nebulizer adapted for infants (particles diameter of 2-2.5 µm).

Enrollment: 168 estimated patients

Sex: All

Ages: 28 days to 18 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infant of less than 18 months old
• infant hospitalized for a 1st episode of bronchiolitis defined as a 1st episode of respiratory difficulty with sibilant and\or crépitants in a viral context (head cold and\or cough and\or fever and\or notion of contage)
• Necessity of an clinical score upper to 4. This clinical score, described by Wang in 1992, is the clinical score classically used in the studies concerning the acute(sharp) bronchiolitis of the infant ( 8,9,12 ). He(it) is at most on 12 points.
• absence of respiratory décompensation requiring an admission in Unity of Pediatric Intensive care
• signature of the Informed consent
• Membership in a national insurance

Exclusion criteria

• Refusal of the parents to participate in the study
• 18-month-old infant hospitalized for acute(sharp) bronchiolitis with a clinical score lower than 4.
• signs of respiratory décompensation requiring a transfer in resuscitation, signs of hypercapnie or episodes of apneas
• histories of bronchiolitis or asthma of the infant
• cardiac underlying pathology, respiratory, neuromuscular, immunodeficient or former premature of less of 34 weeks of amenorrhoea and less than 3 months of corrected age.
• child having set within 6 hours preceding the inclusion a treatment by bronchodilatateurs or corticoids by systematic or inhaled way.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 3 patient groups

conventional jet-nebulizer

Other group

Description:

(particles diameter of 4-5 µm)

Treatment:

Device: nebulisations

a jet-nebulizer adapted for infants

Experimental group

Description:

(particles diameter of 2-2.5 µm),

Treatment:

Device: nebulisations

a mesh-nebulizer adapted for infants

Experimental group

Description:

(particles diameter of 2-2.5 µm).

Treatment:

Device: nebulisations